979 / Monitoring of the off-label use therapy in Clinical Hospital "Sveti Duh"

CROATIA
Classification of the PSP
Type of Patient Safety Practice Safe
 
Clinical Practice (CP)
Related practices from PaSQ database
"Best fit" category of the reported practice
Medication / IV Fluids
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Topic of the reported practice
Patient safety system
Aim and the benefit of the Patient Safety Practice
 
Approved drugs in regulatory sense are approved in indications covered by the summary of product characteristics. Off-label therapy does not imply strict regulatory requirements for efficacy and safety demonstration through clinical trials. Off-label therapy carries potential advantages and disadvantages in clinical practice. Although it permits innovation and earlier access to potentially valuable medications, it undercuts expectations that drug safety and efficacy have been fully elucidated. As part of the continuous tasks, the Committee for medicinal products at Clinical Hospital “Sveti Duh” provides active monitoring and supervision of patients in whom off-label therapy is prescribed through specific monitoring checklists. These checklists are created by a clinical pharmacologist depending on the type of drugs administered with special regard on patient safety monitoring throughout the entire therapy application. Specific data about dose, route, duration of therapy, outcome and follow-up are included as well as history, physical exam and explanation why off-label therapy is needed. Special concern is put on safety issues, depending of drug applied and lists are created individually for each drug and same for all patients receiving it.
Description of the Patient Safety Practice
 
All physicians are obliged to report the use of off-label therapy with detailed explanation of expected benefits for patients. As soon as the Committee for medicinal products receives this report, it makes specific checklist of all data that needs to be reported throughout the administration of off-label therapy including the outcome of the treatment. These checklist are created for every drug individually depending on the concerns and safety issues such therapy might have. The Committee for medicinal products creates a database with all reported off-label medication checklists. It is possible to search within the database and create specific surveillance analyses according to applied therapy. In that way patient safety during off-label therapy is actively monitored and supervised providing additional and exact information to patients and their questions associated with off-label therapy. Only members of Committee for medicinal products and doctors participating in follow-up of the therapy can have continuous access to databases. All other persons who have interest have to gain approval from Ethics Committee.
Attachment of relevant written information and/or photos, as appropriate
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Effectiveness of the Patient Safety Practice
 
Degree of implementation of reported practice
Yes, fully
Level of implementation of reported practice
Institution level
Specific and measurable outcome for the reported practice were defined
Yes
A baseline measurement before implementation of the reported practice was obtained
Yes
A measurement after full implementation of the reported practice was obtained
Yes
Evaluation of a "positive" effect of the reported practice on Patient Safety
The evaluation showed improvements in Patient Safety outcomes
Type of before-and after evaluation
Both/mixed (qualitative and quantitative)
Enclosure of a reference or attachment in case of published evaluation's results
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Health care context where the Patient Safety Practices was implemented
 
Hospital
Transferability
 
Successful implementation of this Patient Safety Practice in other health care settings than above stated
Not known
Specification of implementation in another health care setting(s)
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Successful implementation's level  of this Patient Safety Practice across settings
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Involved health care staff
 
Physicians
Nurses
Pharmacists
Quality manager
Patient Involvement
 
Direct service user's involvement as integral part of this Patient Safety Practice
Not relevant
Specification of the service users or their representatives' involvement in the implementation of this Patient Safety Practice
There is no specified text here
Point of time in which service user or their reprasentatives' involvement takes place
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Active seeking of service users' opinion, feedback, experience, etc. as integral part of this Patient Safety Practice
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Short description of the service users' level of involvement
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Public accessibility of information regarding this Patient Safety Practice to patients and citizens/service users
No
List of sources where public information is accessible
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Implementation of the Patient Safety Practice
 
Existing collaboration with other countries or international organisations related to implementation of this Patient Safety Practice
No
Problems encountering in the implememntation course of this Patient Safety Practice like lack of motivation, no management support, etc.
Yes
List of the most prevelent difficulties encuntered during implementation of this Patient Safety Practice
Lack of knowledge on implementation strategies
List of the most prevalent drivers for a successful implemetation of this Patient Safety Practice
There is no specified text here
Use of any specific incentives to enhance motivation while implementing this Patient Safety Practice
Yes
Description of used incentives, if any.
education
Existence of support or approval by the clinical or hospital management or any other hihg level authority in the implementation process of this Patient Safety Practice
Yes
Costs of the Patient Safety Practices
 
Completion of cost calculation related to this Patient Safety Practice
Yes
Total number of person days required to implement this Patient Safety Practice
Clinical staff: 120
External consultants: 0
Support staff: 24
Managerial staff: 24
Others: 0
Not relevant: 0
Total number of person days required for training as preparation for implementation of this Patient Safety Practice
Clinical staff: 60
External consultants: 0
Support staff: 4
Managerial staff: 4
Others: 0
Not relevant: 0
Total cost in Euro of specific equipment (machines, software, communications supplies, etc.) needed to support implementation of this Patient Safety Practice
10000
Associated cost with a work reduction or foregoing in order to deliver this Patient Safety Practice
1000
Contact information
 
Name: Ivana Mikacic
Country: CROATIA
Organisation: Clinical Hospital "Sveti Duh"
E-mail: imikacic@kbsd.hr
Phone: +385913712712
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